Objectives: To study safety and performance of the MANTA Vascular closure device (VCD) under real world conditions in 10 centers. Background: The MANTA is a novel plug-based device for large bore arteriotomy closure. Methods: We included all eligible patients who underwent transfemoral large bore percutaneous procedures. Exclusion criteria were per operator's discretion and included severe calcification or marked tortuosity of the access vessel, presence of marked obesity/cachexia or a systolic blood pressure above 180 mmHg. The primary performance endpoint was time to hemostasis. Primary and secondary safety endpoints were major and minor access site related vascular complications up to 30 days, respectively. Vascular complications were adjudicated by an independent clinical event committee according to VARC-2 criteria. We performed multivariable logistic regression to estimate the effect of baseline and procedural characteristics on any and major vascular complications. Results: Between February 2018 and July 2019 500 patients were enrolled undergoing Transcatheter aortic valve replacement (TAVR, N = 496), Balloon aortic valvuloplasty (BAV, N = 2), Mechanical circulatory support (MCS, N = 1) or Endovascular aneurysm repair (EVAR, N = 1). Mean age was 80.8 ± 6.6 years with a median STS-score of 2.7 [IQR 2.0–4.3] %. MANTA access site complications were major in 20 (4%) and minor in 28 patients (5.6%). Median time to hemostasis was 50 [IQR 20–120] sec. Severe femoral artery calcification, scar presence in groin, longer procedure duration, female gender and history of hypertension were independent predictors for vascular complications. Conclusion: In this study, MANTA appeared to be a safe and effective device for large bore access closure under real-world conditions.
Bibliographical noteFunding Information:
Mika Laine MD PhD: Received a research grant from Teleflex.
Stefan Toggweiler MD PhD: Is a proctor/consultant for Boston Scientific, New Valve Technology and Abbott Vascular, has received unrestricted research grants from Boston Scientific and Fumedica AG, and is holding equity in Hi‐D Imaging AG.
We like to thank Maarten van Wiechen, Joris F Ooms and Thijmen Hokken (all from Erasmus University Medical Center) for their valuable help in data acquisition and management. We also like to thank Darra Bigelow, Todd Sorzano, Dr Chris Buller, Edward Ramirez, Jill Hutton-Pugh, Karis Oasan and Dara Bigelow (Teleflex Inc.) for assistance with trial logistics.
Nicolas M. Van Mieghem MD PhD: Dr Van Mieghem has received research grants from Medtronic, Boston Scientific, Edwards Lifesciences, Abbott, PulseCath, Essential Medical and Claret. He is advisor to PulseCath, Claret and Essential Medical.
© 2020 The Authors. Catheterization and Cardiovascular Interventions published by Wiley Periodicals LLC.